Duns Number:078497467
Device Description: Body Fat Scale
Catalog Number
Type BF220
Brand Name
Beurer
Version/Model Number
BF221 (Art.-No. 740.79)
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PUH
Product Code Name
Analyzer, Body Composition, Exempt
Public Device Record Key
8c02f8f8-058f-4e5f-a5e7-a6ebf15bfabc
Public Version Date
February 25, 2019
Public Version Number
4
DI Record Publish Date
March 15, 2017
Package DI Number
10852547004266
Quantity per Package
4
Contains DI Package
00852547004269
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |
U | Unclassified | 2 |